Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action is in response to Applicants’ Amendment and Remarks filed on 11/27/2025 in which claims 2 and 3 are cancelled and claims 1, 4 and 5 are amended to change the scope and breadth of the claims. No claims are newly added.
Claims 1 and 4-6 are pending in the instant application and are examined on the merits herein.
Applicants’ declaration of Eunju Ryu submitted on 11/27/2025 under 37 CFR 1.132, is acknowledged and will be further discussed below.
Priority
This application is a National Stage Application of PCT/KR2021/009326, filed on 7/20/2021 The instant application claims foreign priority to KR 10-2020-0140404 filed on 10/27/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 4/13/2023.
Withdrawn Rejections
All rejection(s) of record for claim(s) 2 and 3 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 11/27/2025, with respect to the rejection of claims 1 and 4-6 under 35 U.S.C. 112(a), has been fully considered and is persuasive. Applicant has amended the claims to remove reference to “prevention”. With respect to the scope of “treatment”, Applicants’ arguments, as supported by the affidavit, are persuasive that one of skill in the art would be enabled by the specification to practice a method of treatment by administering the claimed composition. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/27/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(2) as being anticipated by Duboux et al (US 2023/0220327A1), has been fully considered and is persuasive. Duboux does not disclose treating atopic dermatitis. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 11/27/2025, with respect to the rejection of claim 4 under 35 U.S.C. 103 as being unpatentable over Duboux et al (US 2023/0220327A1), in view of Olsson et al. (US 2009/0131510A1), has been fully considered and is persuasive. Duboux does not disclose treating atopic dermatitis and Olsson does not remedy the deficiency of Duboux. The rejection is hereby withdrawn.
Maintained Rejection
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (TW 200927165A, reference of record), in view of Petrut et al. (Rev. Chim., 2019, reference of record).
Huang et al. discloses a method for treating allergy, specifically atopic dermatitis, and decreasing the level of immunoglobulin-E (IgE), by administering a composition comprising lactic acid bacteria (Lactobacillus, Bifidobacterium and Streptococcus) and arabinogalactose. (pp. 2, 6-7; Figure 7; claim 1)
Huang does not teach administering galactose.
Petrut et al. discloses that lactic acid bacteria have an extensive prophylactic or therapeutic use as probiotics and may utilize several carbon sources for proliferation, where galactose was among the preferred carbon sources. (Abstract, Conclusion)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the arabinogalactose with galactose, in the method of Huang, thereby arriving at the instant invention. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). One of ordinary skill in the art would reasonably expect that galactose would be equivalently effective in the method of Huang because Petrut teaches that lactic acid bacteria preferably use galactose as a carbon source. Thus, in replacing arabinogalactose with galactose then co-administering galactose with lactic acid bacteria, one would reasonably expect effective treatment of allergy due to the therapeutic bacteria being administered along with a preferred food source.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Huang/Petrut, has been fully considered but is not persuasive.
Applicant argues that the claims have been amended to limit the scope of the administered composition to that which “consists essentially of” galactose, whereas the administered composition of Huang contains bacteria, which is not essential to the claimed invention. Applicants’ argument is not persuasive because the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). However, for the purposes of searching for and applying prior art under 35 U.S.C. § 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. (see also MPEP § 2111.03) In the instant case, there is no clear indication either in the specification or in the claims, which non-galactose components are excluded, in order to aid in determining the scope of the phrase "consisting essentially of". In particular, there is no mention of bacteria in the specification or any discussion of how the presence of bacteria would materially affect the characteristics of the claimed invention. The primary goal of the instant claims is to treat or alleviate atopic syndrome/dermatitis, which is identical to the goal of Huang. The test is not whether the presence of bacteria is essential to Huang, the test is whether adding bacteria to the instant claims would somehow render the instant claims ineffective for the intended purpose. There is no evidence of record that the addition of bacteria to the claimed invention would change the essential characteristics of the claimed method. Therefore, the teachings of the cited prior art are within the scope of the instant claims.
Applicant is invited to consider amending claim 1 to recite, “A method for treatment or alleviation of immune hypersensitivity-related disease, comprising administering effective amount of a composition consisting and one or more pharmaceutically acceptable or cosmetically acceptable carriers, excipients or diluents selected from the group consisting of fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, sweeteners, flavoring agents, preservatives, oils, water, surfactants, moisturizers, lower alcohols, thickeners, chelating agents, pigments, preservatives, fragrances, emulsifiers, propellants and solvents, to a subject in need of treatment or alleviation of the immune hypersensitivity-related disease, wherein immune hypersensitivity-related disease is atopic syndrome or atopic dermatitis.” and amending claim 5 to recite, “A method of reducing immunoglobulin E, comprising administering a pharmaceutically effective amount of a composition consisting and one or more pharmaceutically acceptable or cosmetically acceptable carriers, excipients or diluents selected from the group consisting of fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, sweeteners, flavoring agents, preservatives, oils, water, surfactants, moisturizers, lower alcohols, thickeners, chelating agents, pigments, preservatives, fragrances, emulsifiers, propellants and solvents, to a subject in need of reducing immunoglobulin E.”, to overcome the outstanding rejection.
The rejection is still deemed proper and is maintained.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (TW 200927165A, reference of record), in view of Petrut et al. (Rev. Chim., 2019, reference of record), further in view of Olsson et al. (US 2009/0131510A1, reference of record).
The method of Huang/Petrut is referenced as discussed above. The combined prior art does not teach a step of identifying a subject in need thereof prior to administering galactose.
Olsson et al. discloses methods of treating or preventing psoriasis or dermatitis comprising identifying a subject in need thereof and administering to the subject, or contacting the subject with, a therapeutically effective amount of one or more compounds. (¶0190)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Huang/Petrut to add a step of identifying a subject in need thereof, based on the disclosure of Olsson. Olsson demonstrates that it is known in the art of treating dermatitis, to first identify a subject in need of dermatitis treatment prior to administering a therapeutically effective compound. Thus, one of ordinary skill in the art would find it prima facie obvious to add such an identification step to the method of Huang/Petrut, thereby arriving at the instant invention.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693